Bowel Preparation for ColonoscopyNCT06728839
Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Colonoscopy Cleansing
A study testing 1L PEG + 50g magnesium sulfate, 3L PEG and 4L PEG in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital.
Trial summary
Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- 1L PEG + 50g magnesium sulfate, 3L PEG and 4L PEG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,329 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old, male or female
- To undergo screening, surveillance and diagnostic colonoscopy
- Signed written informed consent
Who cannot join
- Subjects with therapeutic colonoscopy for colorectal polyps
- Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
- Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
- Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
- Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
- Subjects with constipation (<3 times a week, difficult defecation, dry stool, less amount)
Show all 11Show fewer
- Subjects with serious cardiac and cerebrovascular diseases,suffering from metabolic disease or endocrine disease
- Subjects who had previously undergone colorectal resection
- Women with positive pregnancy tests or pregnancy plans, and women in lactation or allergic to the investigational drugs and their ingredients
- Subjects who are participating in other clinical trials or receiving special drugs
- Subjects with any other conditions that the investigator considered inappropriate for inclusion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial
Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- 1L PEG + 50g magnesium sulfate, 3L PEG, 4L PEG
- Keywords
- Magnesium sulfate, colonoscopy, bowel preparation, adenoma detection rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L PEG + 50g magnesium sulfateDrug
Subjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours.
3L PEGDrug
Subjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.
4L PEGDrug
Subjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 1L PEG + 50g Magnesium sulfate (Group A) | Experimental | Take 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy Receives: Drug: 1L PEG + 50g magnesium sulfate |
| 3L PEG alone (Group B) | Active comparator | Take 3L polyethylene glycol for bowel preparation before colonoscopy Receives: Drug: 3L PEG |
| 4L PEG alone (Group C) | Active comparator | Take 4L polyethylene glycol for bowel preparation before colonoscopy Receives: Drug: 4L PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation rate
Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
Measured: 30minutes
Secondary outcomes (5)
Excellent bowel preparation rate
The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.
Measured: 30minutes
BBPS score (including total score, left colon, transverse colon, and right colon)
Measured: 30minutes
Adenoma detection rate
Measured: 10 days
Bowel preparation completion rate
Measured: 30minutes
Electrolyte levels
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start9 Dec 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University, Daping Hospital of Army Medical University, Ningjin People's Hospital, Zibo Central Hospital, Zhengzhou Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Affiliated Yueqing Hospital of Wenzhou Medical University, Qianfoshan Hospital, The General Hospital of Western Theater Command, Jiangmen Central Hospital, The First Affiliated Hospital of Henan University of Science and Technology, LiuZhou People's Hospital, The Fifth Affiliated Hospital of Zunyi Medical College, Yan'an University Affiliated Hospital, 900th Hospital of PLA Joint Logistic Support Force
- Responsible party
- Sponsor
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728839
- Sponsor's protocol ID
- MGSP-2024
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3.
PubMed 35920250Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.
PubMed 20485282
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Magnesium Sulfate With Low-volume Polyethylene Glycol for Bowel Preparation Before Colonoscopy: A Multicentre, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06728839
- Acronym / sponsor ID
- MGSP-2024
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- Magnesium sulfate, colonoscopy, bowel preparation, adenoma detection rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,329 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Zhengzhou University, The Second Hospital of Hebei Medical University, Daping Hospital of Army Medical University, Ningjin People's Hospital, Zibo Central Hospital, Zhengzhou Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, Affiliated Yueqing Hospital of Wenzhou Medical University, Qianfoshan Hospital, The General Hospital of Western Theater Command, Jiangmen Central Hospital, The First Affiliated Hospital of Henan University of Science and Technology, LiuZhou People's Hospital, The Fifth Affiliated Hospital of Zunyi Medical College, Yan'an University Affiliated Hospital, 900th Hospital of PLA Joint Logistic Support Force
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Magnesium salts such as magnesium citrate are often combined with polyethylene glycol to make the intestinal preparation before colonoscopy, which has shown high cleaning efficacy. Magnesium sulfate combined with polyethylene glycol is less used in the world. This multicenter, randomized, controlled trial is aimed at to evaluate the efficacy and safety of magnesium sulfate combined with low-volume polyethylene glycol for preoperative bowel preparation for colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1L PEG + 50g Magnesium sulfate (Group A) | Experimental | Drug: 1L PEG + 50g magnesium sulfateTake 50g magnesium sulfate and 1L polyethylene glycol for bowel preparation before colonoscopy |
| 3L PEG alone (Group B) | Active comparator | Drug: 3L PEGTake 3L polyethylene glycol for bowel preparation before colonoscopy |
| 4L PEG alone (Group C) | Active comparator | Drug: 4L PEGTake 4L polyethylene glycol for bowel preparation before colonoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years old, male or female
- To undergo screening, surveillance and diagnostic colonoscopy
- Signed written informed consent
Key exclusion criteria (11 listed)
- Subjects with therapeutic colonoscopy for colorectal polyps
- Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder, or acute gastrointestinal bleeding
- Subjects with confirmed or suspected colorectal cancer, inflammatory bowel disease, toxic colitis, or toxic megacolon
- Subjects with renal or liver dysfunction, congestive heart failure or rhabdomyolysis
- Subjects with ascites, suspected electrolyte abnormalities, or uncorrected dehydration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1L PEG + 50g magnesium sulfateSubjects in Group A will use a regimen combining magnesium sulfate and polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. 1 litter of polyethylene glycol is taken at 8pm the day before the colonoscopy and 50 gram of magnesium sulfate is taken 4-6 hours before the colonoscopy, and then drink 2000 ml of water within 2 hours. | Drug | 1L PEG + 50g Magnesium sulfate (Group A) |
| 3L PEGSubjects in Group B will use a regimen with 3L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 3 liters of polyethylene glycol solution is taken in split dosing, with 1 liter taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy. | Drug | 3L PEG alone (Group B) |
| 4L PEGSubjects in Group C will use a regimen with 4L polyethylene glycol for preoperative bowel preparation and undergo colonoscopy. The 4 liters of polyethylene glycol solution is taken in split dosing, with 2 liters taken at 8pm the day before the colonoscopy and 2 liters taken 4-6 hours before the colonoscopy. | Drug | 4L PEG alone (Group C) |
Primary outcome
Adequate bowel preparation rate
Time frame: 30minutes
Defined as the proportion of participants with score ≥ 2 for all colon segment (right-side colon, transverse colon, and left-side colon) according to the Boston Bowel Preparation Scale
5 secondary outcomes
Excellent bowel preparation rate
Time frame: 30minutes
BBPS score (including total score, left colon, transverse colon, and right colon)
Time frame: 30minutes
Adenoma detection rate
Time frame: 10 days
Bowel preparation completion rate
Time frame: 30minutes
Electrolyte levels
Time frame: 8 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 35920250Ge F, Kang X, Wang Z, Zhu H, Liao L, Wang M, Jia J, Lou L, Guo X, Pan Y, Wan J. Low-dose of magnesium sulfate solution was not inferior to standard regime of polyethylene glycol for bowel preparation in elderly patients: a randomized, controlled study. Scand J Gastroenterol. 2023 Jan;58(1):94-100. doi: 10.1080/00365521.2022.2106154. Epub 2022 Aug 3.
- Background: PubMed 20485282Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoshen Li, MD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 1L PEG + 50g magnesium sulfate, 3L PEG and 4L PEG in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoshen Li, MD (86-021-31161365, li.zhaoshen@hotmall.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel preparation rate (time frame: 30minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728839, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.